research on the effectiveness of neurorehabilitation after stroke

Conditions: Stroke; Stroke Acute; Stroke with Hemiparesis; Stroke, Acute; Stroke, Acute, Ischemic; Stroke, Ischemic

Summary: this clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. the study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (bci), and a virtual reality (vr) display. the goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies. key research questions: efficacy: does the new simulator significantly improve arm function compared to standard rehabilitation techniques? bci technology: which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements? vr contribution: how does the integration of vr enhance rehabilitation outcomes? safety and tolerability: what potential side effects or adverse events may arise from using the new simulator? participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display. researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.


Eligibility criteria:
inclusion criteria: * signed written informed consent. * age 18 to 80 years at the time of stroke onset. * early rehabilitation period (up to 6 months post-stroke). * diagnosis of acute cerebrovascular accident confirmed by mri or ct. * upper limb paresis severity between 0 and 3 on the 6-point medical research council (mrc) muscle strength scale. * ability and willingness to comply with the study protocol. * demonstrated motivation for rehabilitation. exclusion criteria: * montreal cognitive assessment scale (moca) score less than 10 points. * hamilton depression rating scale (ham-d) score greater than 18 points. * modified rankin scale (mrs) score greater than 4 points. * pre-existing conditions that cause decreased muscle strength or increased muscle tone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., parkinson's disease, contractures). * advanced arthritis or significant limitation of upper limb range of motion. * absence of part of the upper limb due to amputation for any reason. * any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness). * alcohol abuse or recreational drug use within the 12 months preceding the study. * use of experimental medications or medical devices within the 30 days preceding the study. * inability to comply with research procedures, as determined by the researcher. * the severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation. * visual acuity less than 0.2 in the weakest eye according to the sivtsev visual acuity chart. * unstable angina and/or heart attack within the 30 days preceding the study. * recurrent stroke. * uncontrolled arterial hypertension. * ataxia. * presence of a pacemaker and/or other implanted electronic devices. * use of muscle relaxants. * peripheral neuropathy. * coexisting diseases in an exacerbation or decompensated stage requiring active treatment. * allergic reactions or other skin lesions at the eeg electrode application sites at the time of the study. * acute urinary tract infections. * acute thrombophlebitis. * any form of epilepsy. * benign and malignant neoplasms.

Keywords: stroke rehabilitation brain-computer interface motor imagery robotics virtual reality neurofeedback